The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients

NCT05557825 | Completed

• 1 other identifier: Radiodermatite06
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis treated with PBM and/or PDT. This is a case series report and the study data will be extracted from the medical records of threee head and neck cancer patients with grade 2 to 4 followed up from 2022 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT therapy. Data with positive or negative results will be reported.

Conditions

Radiodermatitis; Acute; Radiotherapy Side Effect; Head and Neck Cancer

Keywords

Radiodermatitits; Radiotherapy; Photobiomodulation; Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)

  RTOG scale assess the degree and intensity of RD. It identifies degree 0 (no reaction), 1 (faint erythema, dry desquamation, epilation, diminished sweating), 2 (moderate, brisk erythema, exudative dermatitis in plaques and moderate edema), 3 (exudative dermatitis, besides cutaneous folds and intense edema) and 4 (ulceration, hemorrhage, necrosis).

  Change from Baseline at 14 days after end of radiotherapy treatment

Secondary Outcomes (1)

• Visual Analog Scale of Pain

  Change from Baseline at 14 days after end of radiotherapy treatment

Other Outcomes (1)

• Lesion Size

  Change from Baseline at 14 days after end of radiotherapy treatment

Study Arms (1)

Radiodermatitis Case Group

03 patients with grade 2 to 4 radiodermatitis after radiotherapy for the treatment of head and neck cancer submitted to a PBM/PDT therapy protocol

Radiation: Photobiomodulation Therapy

Interventions

Photobiomodulation Therapy RADIATION

Focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 830 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy

Radiodermatitis Case Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatient cancer patients undergoing radiotherapy and who show signs of radiodermatitis RTOG II, III or IV

You may qualify if:

• Patients with diagnosis of head or neck cancer
• Must be undergoing Radiotherapy
• Must have a diagnosis of Grade II, III or IV radiodermatitis by RTOG Scale, made during the follow-up of the patient in their routine treatment at the hospital by the oncology team
• who do not present clinical signs of another pathology that justifies the presence of the dermis lesion.

You may not qualify if:

• Critical clinical states;
• End-of-life or palliative care;
• Patients with skin lesions of another cause even when undergoing RT;
• Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.
• Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.
• All contraindications already defined in the routine referral to the outpatient clinic (patients who have an active tumor at the site to be irradiated; individuals with a history of photosensitivity to photonic or light therapy;patients who have undiagnosed lesions in the treatment region; patients using topical photosensitizing medications or creams;cognitive, psychiatric or neurological changes that prevent the free understanding of the PBM therapy

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences

São Paulo, Brazil

Location

MeSH Terms

Conditions

Radiodermatitis; Radiation Injuries; Head and Neck Neoplasms; Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rebeca B Cecatto, M.D. Ph.D.

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Rebeca Boltes Cecatto

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 28, 2022
• Study Start: January 20, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)